Global Host Cell Protein Testing Market Size is valued at US$ 2.2 Bn in 2024 and is predicted to reach US$ 4.5 Bn by the year 2034 at an 7.5% CAGR during the forecast period for 2025-2034.
Host Cell Proteins, or HCPs, are process-associated protein contaminants that the host bacterium produces during the manufacturing and development of biotherapeutics. It has emerged as a crucial step in the production of biopharmaceuticals, ensuring the safety and efficacy of biological products by identifying and quantifying any residual host cell proteins that can trigger immunogenic reactions in patients.
The market for host cell protein testing is primarily driven by the biopharmaceutical industry's explosive growth and the growing complexity of biological products. The U.S. Food and Drug Administration (FDA) reports that 157 biologics license applications (BLAs) were authorized between 2015 and 2020, indicating a steady increase in the number of approved biological goods. This pattern highlights the growing importance of robust HCP testing procedures in ensuring the efficacy and safety of products.
Moreover, the upgrades to biopharmaceutical research facilities and production facilities have been driven by the growing need for drugs to treat various types of cancer and inflammatory conditions. This need is driving the expansion of biopharmaceutical capabilities, which has further boosted the number of drugs produced. Moreover, the host cell protein testing market is expected to expand due to ongoing research & development efforts related to testing, as well as a growing number of regulatory approvals for testing apparatus.
Additionally, the global market would benefit from the impressive technological advancements in HCP testing equipment, with a focus on enhancing its capabilities and adding more features. Thus, this will accelerate the expansion of the host cell protein testing market.
Some of the Key Players in Host Cell Protein Testing Market:
· Promega Corporation
· Eurofins Scientific
· GE Healthcare Life Sciences (Cytiva)
· SGS Life Sciences
· Abcam
· Alphalyse
· BioGenes GmbH
· Charles River Laboratories
· Cygnus Technologies
· Intertek Group
· Kymos Pharma
· Lonza
· MilliporeSigma (Merck KGaA)
· Pacific BioLabs
· Toxikon (Labcorp)
· WuXi Biologics
· BioOutsource (Sartorius)
· Bio-Techne
· PPD (Part of Thermo Fisher Scientific)
· Syngene International
The Host Cell Protein testing market is segmented by service type, product stage, technology, application, expression system, and end-use. By service type, the market is segmented into HCP assay development, ELISA reagent customization, anti-HCP antibody generation, orthogonal method support (e.g., LC-MS confirmation), regulatory support & documentation, HCP quantification & validation, and others. By product stage, the market is segmented into preclinical, clinical (Phase I, Phase II, Phase III), and commercial. By technology, the market is segmented into enzyme-linked immunosorbent assay (ELISA) (Generic ELISA, Custom ELISA, Platform-specific ELISA), 2D Gel Electrophoresis, western blotting, liquid chromatography – mass spectrometry (LC-MS/MS), others (e.g., capillary electrophoresis, emerging biosensor-based assays). By application, the market is segmented into vaccines, monoclonal antibodies (mAbs), enzymes, gene therapy products, biosimilars, recombinant proteins, and others. By expression system, the market is segmented into insect cells, mammalian cells (CHO, HEK 293, others), microbial cells (e.coli, yeast, others), and others (e.g., Plant Cells, Algae-based systems). By End-use, the market is segmented into academic & research institutions, biopharmaceutical & biotechnology companies, contract development and manufacturing organizations (CDMOs), contract research organizations (CROs), and others.
The enzyme-linked immunosorbent assay (ELISA) category dominated the host cell protein testing category because these tests are widely used for detecting host cell proteins in biopharmaceutical products, offering strong sensitivity and specificity. These assays are a very dependable instrument in the industry's quality control procedures and have a long history of successful HCP testing. Their status as the market's top sector has been further cemented by their affordability, ease of use, and reliability in extensive testing.
In 2024, a significant portion of the host cell protein testing market's revenue came from the mammalian cells segment. This is because therapeutic proteins are increasingly being developed using mammalian cells. Because mammalian cells can create stable formulations with high-yield expression, they are used extensively. They are also favoured because they closely resemble human physiology, making them useful for research and the manufacturing of biopharmaceuticals.
The market for host cell protein testing is anticipated to be dominated by North America because of the region's developed healthcare system, substantial firms, and higher R&D expenditures. North America, especially the United States, is regarded as the cornerstone of worldwide expansion due to its abundance of novel drug discoveries. Investments in this industry have increased as a result of the proactive atmosphere this has produced for pharmaceutical R&D culture. Additionally, a strict regulatory environment and the growing demand for innovative treatments are supporting market expansion.
Throughout the projected period, the host cell protein testing market is expected to expand at the fastest CAGR in the Asia-Pacific region. The market is boosted by the quickly developing biopharmaceutical and biotechnology industries, as well as the expanding R&D activities, and the growing number of startups fuels industry growth. Additionally, businesses are required to disclose HCP testing data due to the quickly changing regulatory environment in many nations. Government agencies provide funding for therapeutic protein research and production.
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Host Cell Protein Testing Market Snapshot
Chapter 4. Global Host Cell Protein Testing Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2025-2034
4.8. Competitive Landscape & Market Share Analysis, By Key Player (2024)
4.9. Use/impact of AI on Host Cell Protein Testing Market Industry Trends
4.10. Global Host Cell Protein Testing Market Penetration & Growth Prospect Mapping (US$ Mn), 2024-2034
Chapter 5. Host Cell Protein Testing Market Segmentation 1: Technology, Estimates & Trend Analysis
5.1. Market Share by Technology, 2024 & 2034
5.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Technology:
5.2.1. Enzyme-Linked Immunosorbent Assay (ELISA)
5.2.1.1. Generic ELISA
5.2.1.2. Platform-specific ELISA
5.2.1.3. Custom ELISA
5.2.2. Western Blotting
5.2.3. Liquid Chromatography – Mass Spectrometry (LC-MS/MS)
5.2.4. 2D Gel Electrophoresis
5.2.5. Others (e.g., Capillary Electrophoresis, Emerging Biosensor-based Assays)
Chapter 6. Host Cell Protein Testing Market Segmentation 2: By Expression System, Estimates & Trend Analysis
6.1. Market Share by Expression System, 2024 & 2034
6.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Expression System:
6.2.1. Mammalian Cells
6.2.1.1. CHO
6.2.1.2. HEK 293
6.2.1.3. Others
6.2.2. Microbial Cells
6.2.2.1. E.coli
6.2.2.2. Yeast
6.2.2.3. Others
6.2.3. Insect Cells
6.2.4. Others (e.g., Plant Cells, Algae-based systems)
Chapter 7. Host Cell Protein Testing Market Segmentation 3: By Application, Estimates & Trend Analysis
7.1. Market Share by Application, 2024 & 2034
7.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
7.2.1. Monoclonal Antibodies (mAbs)
7.2.2. Vaccines
7.2.3. Recombinant Proteins
7.2.4. Gene Therapy Products
7.2.5. Enzymes
7.2.6. Biosimilars
7.2.7. Others
Chapter 8. Host Cell Protein Testing Market Segmentation 4: By Service Type, Estimates & Trend Analysis
8.1. Market Share by Service Type, 2024 & 2034
8.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Service Type:
8.2.1. HCP Assay Development
8.2.2. Anti-HCP Antibody Generation
8.2.3. ELISA Reagent Customization
8.2.4. HCP Quantification & Validation
8.2.5. Orthogonal Method Support (e.g., LC-MS confirmation)
8.2.6. Regulatory Support & Documentation
8.2.7. Others
Chapter 9. Host Cell Protein Testing Market Segmentation 5: By Product Stage, Estimates & Trend Analysis
9.1. Market Share by Product Stage, 2024 & 2034
9.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following Product Stage:
9.2.1. Preclinical
9.2.2. Clinical
9.2.2.1. Product Stage I
9.2.2.2. Product Stage II
9.2.2.3. Product Stage III
9.2.3. Commercial
Chapter 10. Host Cell Protein Testing Market Segmentation 6: By End Use, Estimates & Trend Analysis
10.1. Market Share by End Use, 2024 & 2034
10.2. Market Size Revenue (US$ Million) & Forecasts and Trend Analyses, 2021 to 2034 for the following End Use:
10.2.1. Biopharmaceutical & Biotechnology Companies
10.2.2. Contract Research Organizations (CROs)
10.2.3. Contract Development and Manufacturing Organizations (CDMOs)
10.2.4. Academic & Research Institutions
10.2.5. Others
Chapter 11. Host Cell Protein Testing Market Segmentation 7: Regional Estimates & Trend Analysis
11.1. Global Host Cell Protein Testing Market, Regional Snapshot 2024 & 2034
11.2. North America
11.2.1. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
11.2.1.1. US
11.2.1.2. Canada
11.2.2. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
11.2.3. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Expression System, 2021-2034
11.2.4. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
11.2.5. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Service Type, 2021-2034
11.2.6. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Product Stage, 2021-2034
11.2.7. North America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by End Use, 2021-2034
11.3. Europe
11.3.1. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
11.3.1.1. Germany
11.3.1.2. U.K.
11.3.1.3. France
11.3.1.4. Italy
11.3.1.5. Spain
11.3.1.6. Rest of Europe
11.3.2. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
11.3.3. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Expression System, 2021-2034
11.3.4. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
11.3.5. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Service Type, 2021-2034
11.3.6. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Product Stage, 2021-2034
11.3.7. Europe Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by End Use, 2021-2034
11.4. Asia Pacific
11.4.1. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
11.4.1.1. India
11.4.1.2. China
11.4.1.3. Japan
11.4.1.4. Australia
11.4.1.5. South Korea
11.4.1.6. Hong Kong
11.4.1.7. Southeast Asia
11.4.1.8. Rest of Asia Pacific
11.4.2. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
11.4.3. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Expression System, 2021-2034
11.4.4. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
11.4.5. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Service Type, 2021-2034
11.4.6. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Product Stage, 2021-2034
11.4.7. Asia Pacific Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by End Use, 2021-2034
11.5. Latin America
11.5.1. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
11.5.1.1. Brazil
11.5.1.2. Mexico
11.5.1.3. Rest of Latin America
11.5.2. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
11.5.3. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Expression System, 2021-2034
11.5.4. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
11.5.5. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Service Type, 2021-2034
11.5.6. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Product Stage, 2021-2034
11.5.7. Latin America Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by End Use, 2021-2034
11.6. Middle East & Africa
11.6.1. Middle East & Africa Wind Turbine Rotor Blade Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
11.6.1.1. GCC Countries
11.6.1.2. Israel
11.6.1.3. South Africa
11.6.1.4. Rest of Middle East and Africa
11.6.2. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
11.6.3. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Expression System, 2021-2034
11.6.4. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
11.6.5. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Service Type, 2021-2034
11.6.6. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by Product Stage, 2021-2034
11.6.7. Middle East & Africa Host Cell Protein Testing Market Revenue (US$ Million) Estimates and Forecasts by End Use, 2021-2034
Chapter 12. Competitive Landscape
12.1. Major Mergers and Acquisitions/Strategic Alliances
12.2. Company Profiles
12.2.1. Abcam
12.2.1.1. Business Overview
12.2.1.2. Key Product/Service Overview
12.2.1.3. Financial Performance
12.2.1.4. Geographical Presence
12.2.1.5. Recent Developments with Business Strategy
12.2.2. Alphalyse
12.2.3. BioGenes GmbH
12.2.4. BioOutsource (Sartorius)
12.2.5. Bio-Techne
12.2.6. Charles River Laboratories
12.2.7. Cygnus Technologies
12.2.8. Eurofins Scientific
12.2.9. GE Healthcare Life Sciences (Cytiva)
12.2.10. Intertek Group
12.2.11. Kymos Pharma
12.2.12. Lonza
12.2.13. MilliporeSigma (Merck KGaA)
12.2.14. Pacific BioLabs
12.2.15. PPD (Part of Thermo Fisher Scientific)
12.2.16. Promega Corporation
12.2.17. SGS Life Sciences
12.2.18. Syngene International
12.2.19. Toxikon (Labcorp)
12.2.20. WuXi Biologics
Host Cell Protein Testing Market by Service Type-
· HCP Assay Development
· ELISA Reagent Customization
· Anti-HCP Antibody Generation
· Orthogonal Method Support (e.g., LC-MS confirmation)
· Regulatory Support & Documentation
· HCP Quantification & Validation
· Others
Host Cell Protein Testing Market by Product Stage -
· Preclinical
· Clinical
o Phase I
o Phase II
o Phase III
· Commercial
Host Cell Protein Testing Market by Technology-
· Enzyme-Linked Immunosorbent Assay (ELISA)
o Generic ELISA
o Custom ELISA
o Platform-specific ELISA
· 2D Gel Electrophoresis
· Western Blotting
· Liquid Chromatography – Mass Spectrometry (LC-MS/MS)
· Others (e.g., Capillary Electrophoresis, Emerging Biosensor-based Assays)
Host Cell Protein Testing Market by Application-
· Vaccines
· Monoclonal Antibodies (mAbs)
· Enzymes
· Gene Therapy Products
· Biosimilars
· Recombinant Proteins
· Others
Host Cell Protein Testing Market by Expression System-
· Insect Cells
· Mammalian Cells
o CHO
o HEK 293
o Others
· Microbial Cells
o E.coli
o Yeast
o Others
· Others (e.g., Plant Cells, Algae-based systems)
Host Cell Protein Testing Market by End-use-
· Academic & Research Institutions
· Biopharmaceutical & Biotechnology Companies
· Contract Development and Manufacturing Organizations (CDMOs)
· Contract Research Organizations (CROs)
· Others
Host Cell Protein Testing Market by Region-
North America-
· The US
· Canada
Europe-
· Germany
· The UK
· France
· Italy
· Spain
· Rest of Europe
Asia-Pacific-
· China
· Japan
· India
· South Korea
· Southeast Asia
· Rest of Asia Pacific
Latin America-
· Brazil
· Argentina
· Mexico
· Rest of Latin America
Middle East & Africa-
· GCC Countries
· South Africa
· Rest of the Middle East and Africa
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
